Tolerance Clinical Trial
Official title:
Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05592951 -
Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
|
N/A | |
Completed |
NCT04689035 -
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
|
Phase 1 | |
Recruiting |
NCT02129296 -
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
|
Phase 1/Phase 2 | |
Completed |
NCT06114524 -
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
|
N/A | |
Active, not recruiting |
NCT06286488 -
Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza
|
Phase 4 | |
Completed |
NCT04529759 -
Healthy Term Infants Fed Milk-Based Infant Formula
|
N/A | |
Not yet recruiting |
NCT05428748 -
Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
|
N/A | |
Completed |
NCT04499482 -
Safety and Tolerability of Soy Fiber
|
N/A | |
Recruiting |
NCT01207206 -
Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients
|
N/A | |
Completed |
NCT01038882 -
Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
|
N/A | |
Completed |
NCT06187233 -
The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
|
N/A | |
Completed |
NCT04055363 -
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
|
N/A | |
Recruiting |
NCT03707262 -
Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor
|
Phase 1/Phase 2 | |
Completed |
NCT05585762 -
Buck Institute Ketone Ester RCT
|
N/A | |
Completed |
NCT02307773 -
Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy
|
N/A | |
Completed |
NCT04188782 -
Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
|
||
Recruiting |
NCT05527652 -
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
|
N/A | |
Recruiting |
NCT05088694 -
The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.
|
N/A | |
Completed |
NCT06034951 -
Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients
|
N/A | |
Completed |
NCT04651829 -
Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
|